Home NDC 82595-000 UPTRAVI
Product NDC 82595-000
11-digit product format 825950000
Labeler code 82595
Product ID 82595-000_e1037fc6-9b27-5636-e053-2a95a90a6d29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SELEXIPAG
Dosage form POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler EUROFINS AMATSIGROUP SAS
Application NDA214275
Marketing category NDA
Marketing start 2021-07-29
Marketing end 0000-00-00
Substance SELEXIPAG
Active strength 1800 ug/1
Pharmacologic classes Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214275-001 UPTRAVI SELEXIPAG 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214275-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2021-08-27 N214275-001 7205302*PED 2027-04-30 Pediatric extension N214275-001 9173881 2029-08-12 U-1798 2021-08-27 N214275-001 9173881*PED 2030-02-12 Pediatric extension N214275-001 9284280 2030-06-25 U-1831 2021-08-27 N214275-001 8791122 2030-08-01 Drug substance, Drug product 2021-08-27 N214275-001 9284280*PED 2030-12-25 Pediatric extension N214275-001 8791122*PED 2031-02-01 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214275-001 UPTRAVI 1.8MG/VIAL POWDER / INTRAVENOUS RLD, RS 2021-07-29 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 148 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N214275-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2021-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214275-001 7205302*PED 2027-04-30 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214275-001 9173881 2029-08-12 U-1798 2021-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214275-001 9173881*PED 2030-02-12 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214275-001 9284280 2030-06-25 U-1831 2021-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214275-001 8791122 2030-08-01 Drug substance, Drug product 2021-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214275-001 9284280*PED 2030-12-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214275-001 8791122*PED 2031-02-01 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214275-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2021-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214275-001 7205302*PED 2027-04-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214275-001 9173881 2029-08-12 U-1798 2021-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214275-001 9173881*PED 2030-02-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214275-001 9284280 2030-06-25 U-1831 2021-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214275-001 8791122 2030-08-01 Drug substance, Drug product 2021-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214275-001 9284280*PED 2030-12-25 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214275-001 8791122*PED 2031-02-01 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214275-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2021-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214275-001 9173881 2029-08-12 U-1798 2021-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214275-001 9284280 2030-06-25 U-1831 2021-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214275-001 8791122 2030-08-01 Drug substance, Drug product 2021-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214275-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2021-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214275-001 9173881 2029-08-12 U-1798 2021-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214275-001 9284280 2030-06-25 U-1831 2021-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214275-001 8791122 2030-08-01 Drug substance, Drug product 2021-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214275-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2021-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214275-001 9173881 2029-08-12 U-1798 2021-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214275-001 9284280 2030-06-25 U-1831 2021-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214275-001 8791122 2030-08-01 Drug substance, Drug product 2021-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214275-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2021-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214275-001 9173881 2029-08-12 U-1798 2021-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214275-001 9284280 2030-06-25 U-1831 2021-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214275-001 8791122 2030-08-01 Drug substance, Drug product 2021-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214275-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2021-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214275-001 9173881 2029-08-12 U-1798 2021-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214275-001 9284280 2030-06-25 U-1831 2021-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214275-001 8791122 2030-08-01 Drug substance, Drug product 2021-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214275-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2021-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214275-001 9173881 2029-08-12 U-1798 2021-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214275-001 9284280 2030-06-25 U-1831 2021-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214275-001 8791122 2030-08-01 Drug substance, Drug product 2021-08-27 2680178bc6a6…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join UPTRAVI SELEXIPAG Actelion Pharmaceuticals US, Inc. a7a23b87-f892-4e2c-8e2e-ebf841220f90 2026-05-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 214275 application number: NDA214275
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82595-000-01 82595000001 1 VIAL in 1 CARTON (82595-000-01) > 1 POWDER, FOR SOLUTION in 1 VIAL 1 vial 2021-07-29 0000-00-00 No No Current